A tool to facilitate dialogue with a range of relevant stakeholders, to help identify evidence considerations of policy makers.
In many cases, the end goal of clinical research is a change in policy; but there is often a gap between research design and policy needs, which can lead to wasted money and time. The Target Policy Profile (TPoP) tool was developed to address this common and critical issue. The TPoP tool can be used prior to research to identify key evidence needed to support policy decisions and/or at the point of evidence generation and dissemination. The TPoP can help researchers structure engagement with stakeholders to analyze the evidence underlying a given policy, the gaps in that evidence, and the nature of additional evidence needed. The TPoP also aims to facilitate early and ongoing communication between researchers, policymakers, and other global health stakeholders, such as manufacturers and regulators, to name just two. Armed with this knowledge and these relationships, clinical researchers can maximize the likelihood that studies are informative and support the efficient generation of optimal policies.
In many cases, the end goal of clinical research is a change in policy; but there is often a gap between research design and policy needs, which can lead to wasted money and time. The TPoP tool was developed to address this common and critical issue. The TPoP tool can be used prior to research to identify key evidence needed to support policy decisions and/or at the point of evidence generation and dissemination. The TPoP can help researchers structure engagement with stakeholders to analyze the evidence underlying a given policy, the gaps in that evidence, and the nature of additional evidence needed. The TPoP also aims to facilitate early and ongoing communication between researchers, policymakers, and other global health stakeholders, such as manufacturers and regulators, to name just two. Armed with this knowledge and these relationships, clinical researchers can maximize the likelihood that studies are informative and support the efficient generation of optimal policies.
Research shows that inclusion of policymakers in the journey toward research—such as participating in the TPoP process before the TPoP format is settled on and populated—is the factor most associated with a change in policy.
What is the TPoP Tool and what are the benefits of using it?
The TPoP tool consists of a form for researchers to fill out, including prompts and a set of questions as a guide. The benefits of using the TPoP include;
a) Creates next-steps to move research to a policy; b) Identifies stakeholder barriers to move to a new policy; c) Shows how new evidence fits with other facts; d) Focuses all stakeholders on the same facts for a dialogue, and; e) Identifies missing facts that need to be researched.
Who should complete the TPoP?
The TPoP could be completed by a PI or study team. The group creating a TPoP is usually the team advocating a change in policy, who wish to engage the owners of the policy to understand what evidence a policymaker or policymaking organization needs in order to act.
When should one be completed and how is it kept up to date?
It is envisaged that a TPoP would be completed whenever a change in policy is proposed and updated whenever significant new information becomes available that may affect any of the assertions within the TPoP. The TPoP should then be kept current throughout the lifecycle of the policy change.
Who is the audience for a TPoP?
The typical target audience of a TPoP is the policymaking body that decides if, when and how to change policy on how to address a health condition. It is recognized that it is not always possible to directly engage those responsible for a change in policy as a collective and in these circumstances, applying a rigorous approach to reviewing the evidence and identifying the gaps will still serve the policy objectives well. The TPoP could also serve as a tool for the academic community to agree on the current state of knowledge and research gaps. Additional audiences might include various stakeholders. These stakeholders could include research funders, other researchers, global standard organizations, organizations manufacturing, subsidizing or distributing interventions involved in the new policy, as well as technical experts that a policymaker relies on to compile evidence and make recommendations. The purpose of the TPoP document is to facilitate a discussion with all relevant stakeholders.
Engage your target audience early and often
When ready to create your TPoP, first identify the “target audience” for the information you want to communicate. Often policymakers are the target audience. An ideal approach is to engage specific members of your target audience as well as key opinion leaders (KOLs) in early dialog that is intended to draft a “case for change”. This case for change should:
Establish arguments based on robust evidence for why the proposed policy change will save and improve lives.
Summarize the existing approach.
Propose the evidence requirements to justify the proposed change in policy. This will come from research and other implementations, pilots and guidelines.
Highlight existing research and identify any gaps to be filled by further studies, serving as a tool to discuss and agree on approaches including the design of studies to address evidence gaps.
This can be done by including KOLs in a design workshop to draft the key points for your case for change and collaboratively fill in the TPoP template. The output of the initial workshop will often be required research and the planning of new studies to generate necessary evidence. The draft TPoP can be iteratively revised, based on the research and studies you complete and by working in concert with the relevant stakeholders along the way, to keep them involved in the dialog and integrate their feedback, when appropriate.
Filling out the TPoP template
The Target Policy Profile Template is a blank copy of the template for you to fill out. This template includes some questions in red (under the "Proposed Target Policy" column header) that you will need to answer to help you draft your Proposed Target Policy. These questions are for guidance only and should be removed before the template is circulated.
Once completed, the top section of the TPoP Template allows you to outline the specific "case for change story" for your proposed TPoP. If desired, this tabular structure can easily be used to draft a compelling and easy-to-read document to engage policymakers, the research community and/or other stakeholders. Such a document should include: (1) your case for change, including the list of challenges of the current policy that make the newly proposed policy attractive to public health; (2) the benefits of a new policy; (3) if it exists, an exemplar case of the how the proposed policy is performing well in current use somewhere, and (4) the proposed summary of evidence that will be presented to change the policy.
The bottom section of TPoP Template (Target Policy Profile "tool"), once completed, provides a side-by-side comparison of the new/proposed policy, the current policy and the pros/cons of the new policy. The completed table can be included in your TPoP document.
How to cite the TPoP
Any mention of the TPoP tool in publications (including reports, briefings and journal articles) must include the following citation of the source:
"Target Policy Profile (TPoP) Version 1 Design Analyze Communicate (DAC), Bill and Melinda Gates Foundation, 2020. https://doi.org/10.48060/tghn.2".
Target Policy Profile Template
The table below includes the prompt questions (under the "Proposed Target Policy" column header) that you will need to answer to help you draft your Proposed Target Policy. A downloadable version for you to complete is at the bottom of the page.
New or Target Policy Name:
High level Policy Currently in Place:
Ownership of policy:
Authors and consulted parties, Date of Last Revision:
Proposed Target Policy
What are the details of a new approach to the health problem at hand?
What are the details of the current approach to that health problem?
What details of the current policy are you proposing to change?
Reason for the change
What are the challenges with the current policy?
Why would a new policy be better than the current policy?
Benefits of new policy
What are the specific health benefits of switching to a new policy?
What are the specific benefits outside public health vs the old policy?
What evidence is needed to achieve the policy change?
What questions, if answered, would call for a new policy?
What evidence is needed to answer these questions?
Existing evidence supporting a proposed policy change
What evidence already exists to support the proposed change to the policy?
Limitations of existing evidence
What gaps exist in the current evidence base?
Why might existing evidence not generalize to our population?
How clear & informative is research to date?
New or Forthcoming Evidence
What new studies have completed that provide evidence, supporting the proposed change in policy?
What additional studies are currently underway or are planned to provide relevant evidence?
Additional Evidence Needed/Gap
What research has been requested by key policymakers?
What are the residual gaps in evidence that require further research?
How will gaps be filled/plan to generate further evidence
What is the plan to address the identified gaps?
Are there new or follow-on studies that could be completed quickly?
Qualitative Health Benefits
What social, political, economic & quality of life benefits are expected?
What benefits exist in other populations who have the new policy?
Quantitative Health Benefits/cost effectiveness considerations
How many lives saved or QALY benefits come from the new policy?
What cost figures must be invested to achieve those savings?
What geographies, regions and states would receive implementation?
What variables define what areas to target first?
Time & Costs to Implement
How long would it take to ramp up the new policy?
What are the high & low cost estimates over what period?
Feasibility & who is Involved in generating the data
How simple or complex is implementing the new policy?
Who has done a feasibility/practicality/acceptability analysis?
Who is addressing the gaps in the evidence?
Regulatory considerations and PQ, are relevant products eligible for PQ
What regulatory issues or hurdles will need to be met?
What types of qualification have been met or need to be met?
National considerations in target countries?
What national considerations, if any, need to be taken into account related to this proposed policy change? What current political factors might affect perception if policy changes?
Delivery and implementation considerations
What stakeholders, organizations or partners are involved in delivery?
Have any pilots been performed to define implementation?
Will ongoing monitoring be required?
What is the monitoring & evaluation strategy and how will it be evaluated?
Who will measure if the health benefits reach the new policy targets?
Process and timeline for policy engagement
What specific policymakers will be solicited/communicated with?
What is the duration & roadmap for achieving policy change?
Overall risk benefit for the policy proposal
What are the benefits, in summary?
What are the risks, in summary?
Proposed plan going forward
What is your action plan including evidence generation, compilation, presentation to policy makers through to policy change and implementation?
Target Policy Profile Tool
Target Policy Proposed and attributes of product(s)
Indication, Disease, Condition
Envisioned setting for intervention (school, community etc)
Minimum Policy Important Difference (MPID)
Other considerations (different populations/geographies/settings)
Guidelines/Standard of Care (SOC)
Communication & Convenings
Fairness & Acceptability
Current Use Elsewhere
Download the DAC Target Policy Profile (TPoP) Template
The DAC TPoP Template is available in 6 languages.
To download a PDF version of the TPoP template, please click on the relevant link below: